Smart Port CT CT75STSD-VIRecalls & reported problems
Angiodynamics, Inc. · Smart Port CT Single Titanium Port System with Attachable 7.5F x 66cm Silicone Catheter and 8F Introducer Kit (with Valved Introducer) · Class 2 · Implant
All models of Smart Port CT (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787CT75STSDVI1), received between Nov 4, 2022 and Oct 14, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K062414); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Bacterial Infection1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON OR ABOUT (B)(6) 2019, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNARNICS SMARTPORT, REFERENCE NUMBER (B)(4), LOT NUMBER 5486875. THE DEVICE WAS IMPLANTED BY (B)(6) M.D., AT (B)(6) MEDICAL CENTER IN (B)(6)-, FOR THE PURPOSE OF ONGOING TREATMENT FOR HER BREAST CANCER. ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED HERSELF TO FHP GENERAL SURGERY WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO AN INFECTION. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.
Patient problems: Bacterial Infection
MAUDE report 20447547 ↗InjuryNov 4, 2022Fracture; Fracture
A SR. CLINICAL ENGINEER REPORTED AN ISSUE WITH A CT W/7.5FR DET CATH & VI SMARTPORT. DURING A PLACEMENT PROCEDURE, THE DISTAL 29CM OF THE 66CM CATHETER BROKE OFF IN THE PATIENT. THE CATHETER WAS NOT YET TRIMMED, WHEN THE BREAKAGE OCCURRED. ULTIMATELY, THE PROCEDURE WAS ABORTED AND THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO SUCCESSFULLY RETRIEVE THE CATHETER SEGMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.
Patient problems: Foreign Body In Patient
MAUDE report 15734234 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062414. One submission often covers many models, so check the product and lot details in each record.
- Z-1466-2021 · Feb 22, 2021 · TerminatedSmart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of me
- Z-0056-2012 · Aug 1, 2011 · Terminated8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyur
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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